Usual Adult Dose for Allergic Rhinitis

300 IR (index of reactivity) sublingually once a day

Comments:

• For sublingual use only
• For adults 18 to 65 years of age
• Initiate treatment 4 months before the expected onset of each grass pollen season and continue treatment throughout the season.
• The risk of mixed grass allergen may be increased when treatment is initiated during the grass pollen season.

Use: Treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the following five grass species: Sweet Vernal (Anthoxanthum odoratum L), Orchard (Dactylis glomerata L), Perennial Rye (Lolium perenne L), Timothy (Phleum pratense L), and Kentucky Blue Grass (Poa pratensis L).

Usual Pediatric Dose for Allergic Rhinitis

Initial Dose: 100 IR (index of reactivity) sublingually on Day 1 followed by 200 IR sublingually on Day 2.
Maintenance Dose: 300 IR sublingually once a day starting on Day 3

Comments:

• For sublingual use only
• For children and adolescents 10 to 17 years of age
• Administer mixed grass allergen to children under adult supervision.
• Initiate treatment 4 months before the expected onset of each grass pollen season and continue treatment throughout the season.
• The risk of mixed grass allergen may be increased when treatment is initiated during the grass pollen season.

Use: Treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the following five grass species: Sweet Vernal (Anthoxanthum odoratum L), Orchard (Dactylis glomerata L), Perennial Rye (Lolium perenne L), Timothy (Phleum pratense L), and Kentucky Blue Grass (Poa pratensis L).

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:

• Mixed grass allergen can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal edema.
• Do not administer mixed grass allergen to patients with severe, unstable or uncontrolled asthma.
• Observe patients in the office for at least 30 minutes following the initial dose.
• Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.
• May not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.
• May not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

CONTRAINDICATIONS:

• Severe, unstable, or uncontrolled asthma
• History of any severe allergic reaction
• History of any severe local reaction to sublingual allergen immunotherapy
• History of eosinophilic esophagitis
• Hypersensitivity to any of the inactive ingredients

Safety and efficacy have not been established in patients younger than 10 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer the first dose in a healthcare setting under the supervision of a physician with experience in the field.
• After receiving the first dose, observe the patient for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction.
• Administer mixed grass allergen to children under adult supervision.
• Allow the tablet to remain under the tongue until completely dissolved. Do not swallow for at least 1 minute.
• Wash hands after handling the tablet.
• Do not take the tablet with food or beverage. Food or beverage should not be taken for 5 minutes after taking the tablet(s).
• Prescribe auto-injectable epinephrine to patients and instruct them in the proper use of emergency self-injection of epinephrine.

Storage requirements:

• Protect from moisture